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临床试验/EUCTR2009-017182-38-DE
EUCTR2009-017182-38-DE进行中(未招募)不适用

An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease.

Impax Laboratories, Inc. acting through its Impax Pharmaceuticals Division0 个研究点目标入组 500 人开始时间: 2010年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
500

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1.Successful completion of studies IPX066 B08-05, IPX066 B08 11, or IPX066 B09 02.
  • 2.In the opinion of the Investigator, the Parkinson’s disease diagnosis is still valid and the subject remains eligible for LD therapy.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.
  • 2.Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
  • 3.Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline).
  • 4.In the opinion of the Investigator, should not participate in the study.

研究者

发起方
Impax Laboratories, Inc. acting through its Impax Pharmaceuticals Division

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